The Public Health Advisory issued by the FDA is designed to update patients and healthcare providers with the latest information on antidepressant use.
The FDA is taking the issue seriously. The agency says that even before the publication of recent studies linking suicide to antidepressant use, it had already begun the process of reviewing available data to determine whether there is an increased risk.
The agency has asked manufacturers to provide information from their trials using an approach similar to that used in the evaluation of the risk of suicidal behavior in the pediatric population taking antidepressants. This effort will involve hundreds of clinical trials and may take more than a year to complete.
Taking a precautionary stance the FDA has warned that adults being treated with antidepressant medicines, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. The recommendations are consistent with warnings already present in approved labeling for antidepressants used by adults.
The main antidepressants sold in America include Pfizer’s Zoloft, GlaxoSmithKline’s Paxil and Eli Lilly’s Prozac.